This role is in support of Cencoras global logistics and storage services marketed through our World Courier business.

This role as a quality representative plays a crucial role in ensuring compliance with World Courierpolicies and procedures at the local level. They are responsible for overseeing quality-relatedactivities within the Clinical Trial Commercial and Transport divisions of the organization. Theyprovide guidance to office depots and divisional associates on matters of quality and they are responsible for ensuring compliance with local regulatory requirementsrelated to operations and may have regulatory responsibilities in front of local authorities.

Responsibilities:

1) Quality Management System (QMS)

• QMS Management: Developing and maintaining a robust QMS that defines theorganizations quality objectives policies procedures and performance metrics. Thisincludes to act as a first contact for the Country Manager and local team for quality relatedtopics. And to ensure that quality aspects for CCS and Transport are adequately represented during local and global meetings as well as local and global projects andinitiatives.
• Supplier Qualification Management: Oversee the Suppliers Evaluation Program inaccordance with internal guidelines including local suppliers approval / rejection. Thisinvolves working closely with subject matter experts and the local operational team toensure that subcontractors and suppliers meet the necessary qualifications and standards. To ensure supplier meet quality expectations through supplier audits performancemonitoring and corrective actions when necessary.
• Quality Agreements: To review and negotiate quality agreements and ConfidentialityDisclosure Agreements CDAs (Confidentiality Disclosure Agreement) NDAs (Non-Disclosure Agreement) this includes carefully examining the terms andconditions outlined in these agreements ensuring alignment with company policies andregulatory requirements.
• Internal / External Audits Inspections and certification audits: To be the main auditorcontact and to communicate with relevant parties within the organization. To initiate andoversee the audit organization. Respond promptly to auditor inquiries by providingaccurate information supporting documentation or clarification as needed. Work withmanagement teams to develop and follow up action plans for addressing any identifiednon-compliance issues and provide audit responses in due time.
• Incident Management: Review and manage the documentation on incidents. Activelyparticipating in investigations on non-conformities or deviations from established qualitystandards. Provide quality input for investigations root cause analysis andsupport corrective and preventive action initiatives to address root causes. Assisting in thecreation of comprehensive reports and diligently monitoring deviations and subsequentactions as outlined in the specific internal guidelines. Reporting to global QA(Quality Assurance ) and localleadership any deviations or potential that relevant customer complaints are dealt with effectively.
• Risk Management and Change Control: Assist in setting up and to participate in RiskManagement and Change Control processes. To ensure that clients are contacted whenever required in order to communicate changes such as but not limited to expansionsdepot moving process regulatory updates clarifications etc.
• Pest Control and Facility Cleaning: To ensure that pest control and cleaning programs are properly implemented and documented following applicable SOPs.
• Technical Quality Support: Overview and verify technical change controls calibrationmaintenance and qualification / validation program according to internal guidelinessupporting the local facility representative and QA manager technical compliance. Support the review of temperature graphs as defined in applicable SOP (Standard Operating Procedures)
• Documentation Management: Ensuring accurate documentation of all quality-relatedactivities such as SOPs (Standard Operating Procedures) work instructions test records audit reports etc.
• Quality Data Management: To execute all tasks using dedicated software tools such asMaster Control and SharePoint (or other applicable software tools). This includesaccurately inputting and timely updating data attaching relevant documents trackingprogress documenting actions taken and adhering to any specific workflows or processas outlined in the standard operating procedures.

2) Quality Control

• Quality Checks and Control: Implementing processes to monitor product or servicequality throughout the entire lifecycle from design to delivery. This may involve conductinginspections and analyzing data to ensure accurancy and quality of records to identifydefects or areas for improvement.
• Self-Inspection and Quality Checks: Responsible for quality related activities related tothe Self-Inspection Report as well as quality checks as defined in standard procedure.
• Manufacturing ensure that the batch processing and final records related to the relabeling operationare reviewed through QA spot checks and documented appropriately.
• Packaging Material: To conduct Quality checks and release for GMP-related materialsfor secondary repacking activities.
• Packaging/ Labelling: To conduct and document quality checks for secondaryrepacking activities. To review the completeness of the batch packaging records andensure all data are filled in in accordance with World Couriers Good DocumentationPractices procedure.
• To review and approve the repacked products to the client for clients final release anddisposition.
• To ensure that physical batch packaging records are retained and archived.

3) Compliance Assurance

• Ensuring compliance with relevant regulations (local law GDP quality regulations etc)industry standards (such as ISO and relevant GxP standards) customer requirementsand internal policies. Staying up-to-date with changes in regulations and triggering /implementing necessary QMS changes.
• Verifying adherence of World Courier employees to all Company policies andprocedures as applicable to their role and responsibilities through effective monitoringguidance and support during standard process implementation.
• Ensure that World Courier License(s) as well as any other regulatory documentationis/are properly in place and updated as applicable.

4) Quality Training and Education

• Training Program: Developing training programs to educate employees on qualitystandards quality processes and quality techniques. Ensuring that initial and continuoustraining programs are implemented and maintained related to Good Documentation GoodManufacturing Good Distribution and Good Clinical Practices (when applicable).
• Internal Guidelines Training Management: To assign along with the local Management and maintain the local training job codes and local training matrix.
• To monitor training compliance and escalate non-compliance to local management.

5) Process Improvement

• Continuous Improvement: Identifying opportunities for process improvements throughdata analysis and continuous evaluation of existing workflows. This may includeimplementing Lean Six Sigma methodologies or other improvement frameworks incollaboration with the Continuous Improvement department.
• Customer Satisfaction: Participate in client meetings monitoring client feedback and satisfaction levels to identify areas for improvement in services. To enhance the quality ofservice delivered to clients by closely collaborating with the operational team

6) Operational Quality Support (CSS / Responsible Person only)

• Recalls: To support recalls and mock recalls in accordance with applicable internalguidelines and client instructions.
• Destruction: To act as witness during the destruction process for stored products e.g.
• IMP/Clinical Trial Material or commercial products when required.
• Commercial Product Handling (commercial only) to complete inbound quality checks and confirmation of clients disposition in approvalprocess for 3PL.
• To review and authorize the change of product status following client instructions andwithin the scope of applicable Internal Guidelines.
• Confirm clients disposition of returned rejected recalled or falsified products (ifapplicable).
• Confirm clients disposition of approving any returns to saleable stock (if applicable).

7) Others:

• Keeping appropriate records of any delegated duties and execute tasks andresponsibilities as per delegation plan or assigned to the QA support team.
• Any other quality responsibilities assigned by Regional/Global Quality Management.
• Ensuring along with local management / that requirements imposed on certain products bynational law are adhered to.
• To act as a Deputy Responsible Person to World Couriers Wholesale DistributionAuthorization.
• In accordance with the local regulatory requirements the employee is responsible for: performing bona fide checks as defined by local regulation and described in localprocedure.
• Deciding on the final disposition of returned rejected recalled or falsified products andreporting to the local authority.

Education:

• Minimum of a diploma or of a bachelors degree in a relevant field such as pharmacy chemistry biochemistry pharmaceutical sciences logistics or engineering. Adegree in quality management or a related discipline might also be acceptable.

Experience:

• Supervisor basic experience in quality at least 2 to 5 years in the role of the quality Supervisor the employee should have the knowledge andexperience to make all routine decision independently. Supervision and support is enquiredby the line manager for new and more complex situations. Approval of key documents will bedone under supervision of the line manager or by the line manager.

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Skills & Knowledge:

• Good verbal and written interpersonal and communication skills in English and locallanguage.
• Ability to express oneself clearly in conversations interactions and business writing withothers.
• Develop and maintain good relationships with associates at all levels within the companyand with external parties (e.g. clients vendors etc.).
• Good Awareness of Customer Needs.
• Intermediate Awareness of business requirements of the organization.
• Having a high sense of integrity transparency and accountability in all work tasks andinteractions with others.
• Detailed well-organized and able to multi-task and manage multiple projects at the sametime prioritizing required actions accordingly to meet required deadlines.
• Strong drive to remain focused self-motivated and committed to completing or achievingtasks.
• Excellent skills in Microsoft Office (Excel Word and PowerPoint).
• Able to work independently and with a team when required.

What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Affiliated Companies

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race color religion sex sexual orientation gender identity genetic information national origin age disability veteran status or membership in any other class protected by federal state or local law.

The companys continued success depends on the full and effective utilization of qualified individuals. Therefore harassment is prohibited and all matters related to recruiting training compensation benefits promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned